Novo Nordisk receives FDA approval for Saxenda® (liraglutide [rDNA origin] injection) for chronic weight management

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Dec 24, 2014, 05:41 ET

PLAINSBORO, N.J., Dec. 24, 2014 /PRNewswire/ -- Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda^®(liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management. Saxenda^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) in the presence of at least one weight-related comorbid condition.

Novo Nordisk receives FDA approval for Saxenda(R) (liraglutide [rDNA origin] injection) for chronic weight management

Saxenda^® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program, which included more than 5,000 study participants who have obesity (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with comorbidities.¹ Trial data showed that Saxenda^®, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss than diet and physical activity alone.¹

"Many people with obesity suffer from comorbidities. Saxenda^® has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve certain risk factors of weight-related comorbidities," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Currently in the United States, approximately one-third of the adult population lives with obesity,² leaving them at risk of a myriad of conditions that can affect their overall health.³ Current guidelines recognize that a sustained weight loss of 5% to 10% provides significant health benefits for adults with obesity.⁴

"Obesity has many root causes and there is a clear need for additional treatment options to help health care professionals better address our patients' individual conditions and goals for weight management," said Dr. Donna Ryan, professor and associate executive director of clinical research at the Pennington Biomedical Research Center. "The approval of Saxenda^® provides us with a new therapeutic approach for helping our patients achieve and maintain a healthier body weight."

Reflecting on the approval of Saxenda^® and its impact, Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, said: "Obesity often has serious health consequences, but it has long been underdiagnosed and undertreated. We welcome new tools in the fight against obesity and anticipate that it will be a catalyst to further progress in the understanding and treatment of this complex disease."

Novo Nordisk expects to launch Saxenda^® in the United States in the first half of 2015.

Indications and Usage

Saxenda^® (liraglutide [rDNA origin] injection) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m² or greater (obese) or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use

Saxenda^® is not indicated for the treatment of type 2 diabetes.
Saxenda^® should not be used in combination with any other GLP-1 receptor agonist.
Saxenda^® should not be used with insulin.
The effects of Saxenda^® on cardiovascular morbidity and mortality have not been established.
The safety and efficacy of coadministration with other products for weight loss have not been established.
Saxenda^® has not been studied in patients with a history of pancreatitis.

For full prescribing information, please go to www.Saxenda.com.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda^® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Saxenda^® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk of MTC with use of Saxenda^® and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda^®.

Contraindications
Saxenda^® is contraindicated in the following conditions:

Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components
Pregnancy

Warnings and Precautions

Acute Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Saxenda^® observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Saxenda^® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Saxenda^® should not be restarted.
Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Saxenda^®-treated patients than in placebo-treated patients even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
Serious Hypoglycemia: When Saxenda^® is used with an insulin secretagogue (e.g., a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.
Heart Rate Increase: For patients who experience a sustained increase in resting heart rate while taking Saxenda^®, Saxenda^® should be discontinued.
Renal Impairment: Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Saxenda^® in patients with renal impairment.
Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda^® and promptly seek medical advice.
Suicidal Behavior and Ideation: Patients treated with Saxenda^® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Saxenda^® in patients who experience suicidal thoughts or behaviors. Avoid Saxenda^® in patients with a history of suicidal attempts or active suicidal ideation.

Adverse Events

The most common adverse reactions, reporting in ≥5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

Use in Specific Populations

Nursing mothers should either discontinue Saxenda^® or discontinue nursing.
Safety and effectiveness of Saxenda^® have not been established in pediatric patients and is not recommended for use in pediatric patients.

About obesity
Obesity is a disease that requires chronic management.^5-7 It is a complex and multifactorial disease that is influenced by genetic, physiological, environmental and psychological factors.⁸

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.^9,10 In the United States, approximately one-third of adults, or some 80 million adults, live with obesity.²

Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Further information
Media:
Mike Rulis	+45 4442 3573	[email protected]
Ken Inchausti (U.S.)	+1 609 514 8316	[email protected]
Sharon Corbitt (U.S.)	+1 609-786-4003	[email protected]

Investors:
Kasper Roseeuw Poulsen	+45 3079 4303	[email protected]
Jannick Lindegaard Denholt	+45 3079 8519	[email protected]
Daniel Bohsen	+45 3079 6376	[email protected]
Frank Daniel Mersebach (U.S.)	+1 609 235 8567	[email protected]

References

¹ Data on file. Novo Nordisk Inc; Plainsboro, NJ.
² Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
³ Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999;282(16):1523-1529.
⁴ Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25_PA):2985-3023.
⁵ American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. Accessed September 8, 2014.
⁶ Mechanick JI, Garber AJ, Handelsman Y, Garvey WT. American Association of Clinical Endocrinologists' position statement on obesity and obesity medicine. Endocr Pract. 2012;18(5):642-648.
⁷ Hill JO. Dealing with obesity as a chronic disease. Obes Res. 1998;6(S1):34S-38S.
⁸ Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012; 37(5):730-732.
⁹ World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated August 2014. Accessed August 11, 2014.
¹⁰ Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.